GMP-compliant Mass Production
Proven on an FDA IND-approved nanozyme.
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GMP and non-GMP manufacturing services ensure nanomedicines are produced to global clinical and commercial standards. Our experience covers the full cycle of Cenyx Biotech's cerium oxide nanozyme, developed on the INNOSURFACE® platform and the first cerium oxide-based nanozyme to achieve FDA IND approval, from R&D to manufacturing for clinical studies. Drug substance is produced in our DS GMP facility (4F), and clinical fill-finish can continue in-house in our Drug Product facility (3F).
Photos of GMP facility at OmniParticles
What we offer
1
GMP & non-GMP manufacturing
Drug substance manufacturing from preparation to purified bulk, with GMP-compliant processes for consistency, reliability and safety.
2
Analysis (QC/QA)
Comprehensive QC/QA protocols verify nanomedicine integrity, safety and performance against global regulatory standards.
3
Documentation
Batch records, manufacturing reports and CoT/CoA with full traceability to support FDA, EMA and MFDS filings.
4
CMC documentation & Module 3
CTD dossiers and essential CMC documentation prepared for global regulatory submissions, with detailed Module 3 scientific and technical writing structured for FDA, EMA and APAC requirements.
5
Regulatory consulting
Expert guidance on early-development regulatory strategy and global frameworks, supporting clinical trial applications (IND) and beyond. When the batch is ready for vials, our Drug Product team takes it into sterile fill-finish in the same building.